Edwards Lifesciences, LLC: FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure monitoring.

Hazard

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Details from the source

Reason for recall: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. Distribution: US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA WA WI WV WY OUS: Argentina Australia Austria Bahrain Belgium Brazil Canada CANARY ISLANDS Chile Colombia Costa Rica Czech Republic Denmark Ecuador Faroe Islands France Germany Greece Guatemala Hong Kong Indonesia Ireland Israel Italy Japan Malaysia Nether Quantity: 11,072 units Lot/code info: MHD6AZ: UDI:00690103194722, Lot #: 64818047 64858313 64891437 64953982 MHD6AZ5: UDI: 00690103194746, Lot #: 64782419 64882668 64912054 64918246 64933574 64988043 65007223 65007224; MHD6C502: UDI: 00690103194760, Lot #: 64951410

UPC codes

00690103194722, 00690103194746, 00690103194760

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.